Associate, Quality Assurance (GLP)

Employer
PaxVax
Location
San Diego
Posted
Apr 16, 2018
Required Education
Bachelors Degree
Position Type
Full time

PaxVax is seeking a Quality Assurance (QA) Associate with experience in drug development and clinical sample testing. Reporting to the Director, Quality Assurance, the QA Associate will provide Quality support for the manufacture and testing of non-clinical and clinical products and clinical samples. The QA Associate will be accountable for assuring compliance with Quality Systems, quality oversight at the project level and generation of metrics to drive continuous improvement, while assuring the quality of materials manufactured and data generated.

Responsibilities:

  • Provide guidance to new cGLP laboratory on development of process
  • Ensure compliance of GLP laboratory
  • Provide QA oversight of testing of clinical trial samples
  • Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments
  • Review of  associated analytical data related to the clinical laboratory testing
  • Supports equipment instrument qualification activities
  • Write, review and approve GLP documentation (SOPs, protocols, reports)
  • Aid in implementing process improvements with respect to Quality Assurance
  • Supports external agency and internal audits as required

 Qualification Requirements:

  • BS in Biological sciences, Chemistry or relevant discipline
  • A minimum of 5 years  relevant  experience  in the pharmaceutical/ biotech / clinical laboratory industry
  • 2 + years of increasing responsibility and relevant QA experience in a pharmaceutical/biotechnology environment supporting GLP activities
  • Working knowledge of cGLP principles with respect to FDA and EMA regulations
  • Experience in reviewing and approving cGLP related documents (data packages, equipment qualification, SOPs, protocols, reports)
  • Experience in deviations,  investigations, determining root cause, and developing corrective action plans
  • Knowledge of drug development process
  • Ability and demonstrated experience to identify technical laboratory problems and suggest resolution of issues
  • Ability to independently analyze/resolve moderate issues.
  • Demonstrated initiative and accountability in a fast paced environment.
  • Demonstrated proficiency in application of QA principles, concepts, industry practices and standards
  • Problem solving skills, effective written and verbal communication skills
  • Excellent documentation skills and attention to detail
  • Highly organized and ability to manage multiple priorities
  • Ability to work independently and with various work groups
  • Working knowledge of MS Office suite (Word, Power Point, Excel)

Physical Demands/work environment:

  • Some evening/weekend work may be required to support laboratory testing on occasion
  • Ability to work in cleanroom environment
  • Ability to sit  for a long periods of time; majority of work is computer based

Travel:

  • None